ISO 13485

ISO 13485

Product catalog summary

Certificate Overview: This document certifies that Changzhou Centrau Medical Instrument Co., Ltd. operates a Quality Management System in compliance with ISO 13485:2016 standards.

Scope of Certification: The certification covers the manufacture of non-sterile surgical orthopedic instruments and dental instruments.

Certificate Details:

  • Certificate Number: MD 821620
  • Original Registration Date: July 29, 2025
  • Effective Date: July 29, 2025
  • Expiry Date: July 28, 2028

Issuing Authority: The certificate is issued by BSI, represented by Graeme Tunbridge, Senior Vice President Global Regulatory & Quality.

Verification and Validation: The certificate can be authenticated online and printed copies can be validated through BSI's website or by contacting their offices.

Surveillance Audits: The certified organization must undergo periodic surveillance audits to maintain the validity of the certificate.

Contact Information: BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands. Tel: +31 20 3460 780. China Headquarters: 2008 East Ocean Centre, 24A Jianguomenwai, Beijing, 10004, China. Tel: +86 10 85073000.

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Catalog excerpts

ISO 13485-1

Certificate of Registration QUALITY MANAGEMENT SYSTEM - ISO 13485:2016 质量管理体系 ISO 13485:2016 This is to certify that: 兹证明 Changzhou Centrau Medical Instrument Co., Ltd. (Building 5) No.5, Hexiang Road Jiangsu Wujin Economic Development Zone Changzhou 213000, China Holds Certificate No: 持有证书 and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for the following scope: 并运行符合 ISO 13485:2016 要求的质量管理体系,认证范围如下: The manufacture of non-sterile surgical orthopedic instruments and dental instruments. 非无菌外科骨科器械和齿科器械的制造。 Graeme Tunbridge, Senior Vice President Global Regulatory & Quality Original Registration Date 首次发证日期: 2025-07-29 Effective Date 生效日期: 2025-07-29 Latest Revision Date 最新发证日期: 2025-07-29 Expiry Date 有效期至: 2028-07-28 Page: 1 of 1 This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract. 此证书的所有权属于BSI并受合同条款的约束 An electronic certificate can be authenticated online. 可以 在线 查询电子证书的有效性。 Printed copies can be validated at www.bsi-global.com/ClientDirectory or telephone +86 10 8507 3000. 打印的证书可以通过网站 http://www.bsi-global.com/ClientDirectory或者致电 +86 10 8507 3000 查询。 The information of this certificate can also be found on the official website of the National Certification and Accreditation Administration (www.cnca. gov.cn) 本证书信息亦可在国家认证认可监督管理委员会官方网站 (www.cnca.gov.cn) 上查询。 The certified organization shall be subject to surveillance audit periodically with acceptable results for maintaining the validity of this certificate. 获证组织必须定期接受监督审核并经审核合格此证书方继续有效。 Information and Contact: BSI Group The Netherlands B.V., John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands | Tel: +31 20 3460 780 BSI Group The Netherlands B.V. is registered in The Netherlands under number 33264284 | A

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